Poirier S.A.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Poirier S.A.” (first 1984, latest 1984), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 38 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IQC | Wheelchair, Special Grade | 10 | 10 |
| IOR | Wheelchair, Mechanical | 2 | 2 |
| INM | Chair, With Casters | 1 | 1 |
| IPL | Wheelchair, Standup | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
| KNN | Components, Wheelchair | 1 | 1 |
Plus 1 more product codes.
Review panels
- Physical Medicine (16)
Most recent Poirier S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840638 | PORTABLE TRANSIT CHAIR | INM | 1984-03-16 | 56 |
| K840639 | POIRIER COMMODES | — | 1984-03-09 | 49 |
| K840640 | POSITELEC WHEELCHAIR | ITI | 1984-02-27 | 38 |
| K840637 | HOSPITALIER WHEELCHAIR | IOR | 1984-02-27 | 38 |
| K840636 | CHILDREN'S WHEELCHAIRS | IQC | 1984-02-27 | 38 |
| K840635 | TRAINING WHEELCHAIR | IQC | 1984-02-27 | 38 |
| K840634 | OLYMPIC & BASKET WHEELCHAIRS | IQC | 1984-02-27 | 38 |
| K840633 | AIRPORT WHEELCHAIR | IOR | 1984-02-27 | 38 |
| K840632 | HEMIPLEGIC WHEELCHAIR | IQC | 1984-02-27 | 38 |
| K840631 | ARNAS WHEELCHAIR | IQC | 1984-02-27 | 38 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Poirier S.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Poirier S.A.?
FDA lists 17 510(k) clearances under the applicant name “Poirier S.A.” (first 1984, latest 1984), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Poirier S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Poirier S.A. is 38 days.
Which FDA product codes appear under Poirier S.A.?
The most frequent FDA product codes under this applicant name are IQC (Wheelchair, Special Grade, 10); IOR (Wheelchair, Mechanical, 2); INM (Chair, With Casters, 1).
Next steps
- See all 17 Poirier S.A. clearances with predicates and recalls
- Run predicate analysis for product code IQC, Poirier S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.